Product Wiki · Recalls · U.S. FDA — Device Enforcement

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket — recall Z-0053-2025

U.S. FDA — Device Enforcement · United States · 2024-08-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0053-2025
Date of alert
2024-08-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10195327384494
Reported risk: CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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